Podcasts about Harmonization

Inside the Inspired Evolution Circle we gather every week for practices, breathwork, astrology, deep dives, and live sessions with incredible guest teachers like David.Not just daily prompts or prerecorded content — the Circle is INTERACTIVE, alive, real-time, and built on true human connection.

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In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and ISO 13485, their 1996 origins, and the drive for harmonization that began in 2018. Key insights include the alignment with ISO 13485, additional FDA-specific expectations, the continued importance of risk management, the removal of certain industry exemptions, and the urgent two-year compliance timeline ending in February 2026. Subhi emphasizes the necessity of updating internal quality management systems and training staff to meet these new regulatory requirements.Timelines:00:00 Introduction to FDA QMSR00:29 Historical Context and Timeline02:22 Key Takeaway 1: Harmonization with ISO 1348504:06 Key Takeaway 2: FDA's Additional Expectations05:18 Key Takeaway 3: Risk Management Expectations06:18 Key Takeaway 4: Removal of Exemptions07:44 Key Takeaway 5: Compliance Deadline09:13 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Dan Bowyer, Lomax, and Mads Jensen reunite to talk about the stories behind the headlines - Trump's tariffs, EU's sluggish startup strategy, the Anthropic surge, and why Europe's hardware design hopes might rest on Munich.From missiles interrupting pool time in Tel Aviv to Nvidia's record-breaking quarter, the crew tackles everything from macro trade wars to micro founder incentives—plus a healthy dose of sarcasm, realpolitik, and startup survival.Here's what's covered:04:30 Tariffs, trade wars & what it means for European startups08:15 Harmonization vs. regulation: Why EU/US divergence matters10:55 Tariffs & inflation: Why macro still rules the game13:10 The public/private schism and bond market dismay21:45 The EU startup plan: blue carpets, unicorn labs & old ideas26:00 Talent, tax & the fight for Europe's future founders29:30 Why Munich might be Europe's next deep tech capital31:00 Big tech flexes: Google, Anthropic, and the return of hardware35:00 Vibe coding & SaaS disruption: The new normal?41:00 AI agents, Nvidia blowouts, and the pace of change45:20 Deal of the Week: Brightflag exits for $425M57:00 Why the crew skipped SuperVenture to actually build stuff

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

 In this episode, we chat about using multiple large scale neuroimaging datasets for developmental cognitive neuroscience research. We highlight two exciting recent projects, including the Reproducible Brain Charts database and a foundational study on white matter development. Along the way, we chat about harmonizing multiple datasets, testing in multiple datasets for generalizations, replicability, practical challenges, and more. Matt is joined by two wonderful guests from Dr. Ted Satterthwhaite's lab who are pioneering these momentous efforts - Dr. Golia Shafiei and Audrey LuoReach out to our host:Matt Mattoni (matt.mattoni@temple.edu)Connect with our guests:Dr. Golia Shafiei: https://bsky.app/profile/goliashf.bsky.socialAudrey Luo: https://bsky.app/profile/audreycluo.bsky.social Connect with us on social media! We are always looking for ideas for episode topics, co-hosts, or guests. @FluxSocietyKey Resources:Reproducible Brain ChartsTwo Axes of White Matter DevelopmentReproducibilibuddyhttps://reprobrainchart.github.io/ 

 - ICYMI: Yesterday's post-presser commentary from Ashe & Gordon, while we wait for government to start  - DOGE: Ways and Means Committee reviews resolutions on government access to finances, Social Security  - President Trump welcomes Irish Prime Minister Michael Martin  - CONTINUED: Ways and Means Committee reviews resolutions on government access to finances, Social Security  - President Trump's Bilateral Meeting with the Taoiseach of Ireland, Irish PM Michael Martin  - CONTINUED: Ways and Means Committee reviews resolutions on government access to finances, Social Security  - President Trump, Speaker Mike Johnson, and Irish Prime Minister Michael Martin speak at the White House Luncheon  - President Trump speaks at the Business Round Table (from 3.11.25)  - Senate Commerce, Science, and Technology Committee on Subpoenas - Commentary from Ashe in America  - House Subcommittee on Cybersecurity and Infrastructure Protection Hearing "Regularity Harm or Harmonization? Examining the Opportunity to Improve the Cyber Regulatory Regime" - House Foreign Affairs Africa Subcommittee: Conflict and Persecution in Nigeria

In this episode, I sit down with Stephen Smith, founder of the Center for Building, to uncover the labyrinthine world of building codes—how they're made, who really influences them, and why they end up stifling the very innovation and affordability we need. From the peculiarities of elevator requirements to the often overlooked role of local politics and special interests, we unpack how these complex rules shape our homes, buildings, and cities more than we might realize.TAKEAWAYSWhy Building Codes Matter: Even if you're not a builder or developer, codes dictate your home's layout, the price of housing, and whether your favorite small condo project can even get off the ground.The ICC (International Code Council) Isn't Really “International”: You'll learn how this non-governmental body, which writes most U.S. building codes, can be both extremely influential and surprisingly insular.Over-Regulation's Real-World Costs: We break down how elevator mandates, fire codes, and accessibility requirements—though well-intended—sometimes create perverse incentives that drive up costs or discourage better solutions.Local Politics & Hidden Interests: Discover how “government members” and private manufacturers shape these codes, and why your mayor or city council may have little say in regulations that affect everyone.A Path Forward: Stephen shares practical ways policymakers and citizens can get involved in reforming the system, focusing on a more human-centered approach that balances safety, cost, and beautyCHAPTERS00:00 The Challenge of Building Codes in the U.S.03:06 The Role of Building Codes in Urban Development05:46 Understanding the American Way of Building09:09 The Impact of Building Codes on Housing Costs12:09 Elevator Regulations and Their Consequences14:52 Harmonization of Codes and Standards18:11 Over-Dimensioning in American Construction21:05 Labor Issues in the Construction Industry23:57 The Need for Code Review and Justification26:49 The Tyranny of Bureaucracy in Building Codes38:49 The Grenfell Fire and Its Aftermath45:05 Design Innovations in Building Codes48:25 Understanding the ICC and Code Writing58:09 The Revolving Door: Industry and Regulation01:07:26 The Role of Government in Building Codes01:15:20 Getting Involved: Supporting Change in Building CodesCONNECT WITH STEPHENCenter for Building https://www.centerforbuilding.org/BlueSky: https://bsky.app/profile/stephenjacobsmith.com Email: stephen@centerforbuilding.orgMENTIONED RESOURCESElevator research: https://admin.centerforbuilding.org/wp-content/uploads/2024/12/Elevators.pdf CONNECT WITH AUSTIN TUNNELLNewsletter: https://playbook.buildingculture.com/https://www.instagram.com/austintunnell/https://www.linkedin.com/in/austin-tunnell-2a41894a/https://twitter.com/AustinTunnellCONNECT WITH BUILDING CULTUREhttps://www.buildingculture.com/https://www.instagram.com/buildingculture/https://twitter.com/build_culturehttps://www.facebook.com/BuildCulture/SPONSORSThank you so much to the sponsors of The Building Culture Podcast!Sierra Pacific Windows: https://www.sierrapacificwindows.com/One Source Windows: https://onesourcewindows.com/

Send us a textWelcome friend to this week's update! This week's themes:✨Harmonization & Empowerment ✨Befriending Fear✨Healing Wounds around not being supported ✨Resurrection of Old Dreams✨Rest & Celebration Enjoy! Support the showSubscribe to gain Eclusive Podcast Episodes!https://www.buzzsprout.com/1233209/subscribeSubscribe for Monthly Healing Sessions:(readings, reiki, and channeling)https://www.rebeccameisl.com/category/all-productsSubscribe to My YoutTube Channel@RebeccaMeislContact Rebecca Rebeccameisl.comRebecca.meisl@hotmail.comInstagram & Tik Tok - @rebeccameisl

This week Leonard Bailey, Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit for the Department of Justice (DOJ), Criminal Division, joins us this week. We dive into the role of the DOJ in addressing the vast and ever-changing landscape of cybersecurity. Bailey shares insights on partnering with federal agencies as well as the private sector, navigating information sharing pathways, evolution of incident and cyber threat reporting procedures, and the recent release of the Harmonization of Cyber Incident Reporting to the Federal Government. He also helps debunk information sharing myths and spotlights available tools and benefits of cyber threat information disclosure.   Leonard Bailey The Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit and Special Counsel for National Security in the Department of Justice's (DOJ) Criminal Division. He has prosecuted computer crime cases and routinely advised on cybersecurity, searching and seizing electronic evidence, and conducting electronic surveillance. He has managed DOJ cyber-policy as Senior Counselor to the Assistant Attorney General for the National Security Division and then as an Associate Deputy Attorney General. He has also served as Special Counsel and Special Investigative Counsel for DOJ's Inspector General. Bailey is a graduate of Yale University and Yale Law School. He has taught law courses at Georgetown Law School and Columbus School of Law in Washington, DC. For links and resources discussed in this episode, please visit our show notes at https://www.forcepoint.com/govpodcast/e317

Accelerometer Harmonization Methods (Pt1) - ProPASS Webinar - Prof. Ulf Ekelund and Dr. Jakob Tarp   Part 1. This is audio from ProPASS ECR network webinar. In the third webinar (2nd December) we will hear from Prof. Ulf Ekelund and Dr. Jakob Tarp on harmonization methods. Pooling individual participant data from several research projects may not always be feasible. This talk will cover examples of meta-analyses/data harmonizations performed without transfer of original data. --- The Prospective Physical Activity, Sitting and Sleep consortium (ProPASS) ProPASS is an international research collaboration platform of cohorts using thigh-worn accelerometry to explore the effects of physical activity, posture, and sleep patterns on a wide range of health outcomes. The objectives of the consortium are: to establish a pooled data resource on physical activity, posture allocation, sleep, and health outcomes. to develop methods for processing, harmonizing, and pooling data of existing such studies. to develop methods for collecting data for future studies (prospective harmonization). The ultimate goal of the ProPASS consortium as a data resource is to promote collaborative individual participant and prospective meta-analyses on physical activity, posture, and sleep.  --- This podcast episode is sponsored by Fibion Inc. | Better Sleep, Sedentary Behaviour and Physical Activity Research with Less Hassle --- Collect, store and manage SB and PA data easily and remotely - Discover ground-breaking Fibion SENS --- Learn more about Fibion Flash - a versatile customizable tool with HRV and accelerometry capability.  --- SB and PA measurements, analysis, and feedback made easy.  Learn more about Fibion Research. --- Learn more about Fibion Sleep and Fibion Circadian Rhythm Solutions. --- Fibion Kids - Activity tracking designed for children. --- Explore our Wearables,  Experience sampling method (ESM), Sleep,  Heart rate variability (HRV), Sedentary Behavior and Physical Activity article collections for insights on related articles. --- Refer to our article "Physical Activity and Sedentary Behavior Measurements" for an exploration of active and sedentary lifestyle assessment methods. --- Learn about actigraphy in our guide: Exploring Actigraphy in Scientific Research: A Comprehensive Guide. --- Gain foundational ESM insights with "Introduction to Experience Sampling Method (ESM)" for a comprehensive overview. --- Explore accelerometer use in health research with our article "Measuring Physical Activity and Sedentary Behavior with Accelerometers ". --- For an introduction to the fundamental aspects of HRV, consider revisiting our Ultimate Guide to Heart Rate Variability. --- Follow the podcast on Twitter https://twitter.com/PA_Researcher  Follow host Dr Olli Tikkanen on Twitter https://twitter.com/ollitikkanen  Follow Fibion on Twitter https://twitter.com/fibion  Check our YouTube channel: https://www.youtube.com/@PA_Researcher       

Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space. 00:00 Introduction and Personal Insights 00:28 Defining Harmonization 02:38 Challenges in Regulatory Harmonization 03:43 Operational Harmony and Internal Collaboration 10:38 Sponsor and CXO Harmonization 14:15 Internal Drug and Device Harmonization 17:37 Solutions and Final Thoughts 20:41 Conclusion and Thank You ---------------------------------------- This talk was given at the PharmaED Resources Pre-filled Syringes & Injection Devices 2024 Conference: Exploring the Future of Parenteral Combination Products December 4-5, 2024, La Jolla, CA Note: Apologies for the audio not being of the quality you're used to —this is after hours of post-production. Trust me, the original was worse.

This interview was recorded for the GOTO Book Club.http://gotopia.tech/bookclubRead the full transcription of the interview here:https://gotopia.tech/episodes/323Gregor Hohpe - Author of "Platform Strategy", "The Software Architect Elevator", et al.James Lewis - Software Architect & Director at ThoughtworksRESOURCESGregorhttps://twitter.com/ghohpehttps://www.linkedin.com/in/ghohpehttps://architectelevator.comJameshttps://twitter.com/boicyhttps://linkedin.com/in/james-lewis-microserviceshttps://github.com/boicyhttps://www.bovon.orgDESCRIPTIONJames Lewis and Gregor Hohpe discuss the concept of dimensionality in decision-making, particularly in the context of innovation versus standardization. Hohpe emphasizes the importance of understanding and removing constraints to unlock new opportunities, citing historical shifts in technology and platform thinking as key examples.They explore how traditional one-dimensional views often limit progress and the challenges of adapting to new paradigms, especially in organizations. The discussion also touches on the role of architects in facilitating these shifts and the strategic focus needed for internal platforms to thrive in the face of evolving technologies.RECOMMENDED BOOKSGregor Hohpe • Platform Strategy • https://amzn.to/4cxfYdbGregor Hohpe • The Software Architect Elevator • https://amzn.to/3F6d2axGregor Hohpe • Cloud Strategy • https://amzn.to/3TOS3NvGregor Hohpe • Enterprise Integration Patterns, Vol 2 • https://amzn.to/3TNedQ3Gregor Hohpe & Bobby Woolf • Enterprise Integration Patterns • https://amzn.to/3DqII9lGregor Hohpe • 37 Things One Architect Knows About IT Transformation • https://amzn.to/3z8uhnwTwitterInstagramLinkedInFacebookLooking for a unique learning experience?Attend the next GOTO conference near you! Get your ticket: gotopia.techSUBSCRIBE TO OUR YOUTUBE CHANNEL - new videos posted daily!

Please join Madelina Light and me as we talk about ReActivating Your Heart's Infinite Potential to Create MIRACLES! ​. Join ​us to explore: -What are The Magical Gifts of The 2024/ 888 Lion's Gate - Galactic StarGate Portal, Available for All of Us Now? (Lion's Star Beings Team - Message) -How The Abundant Sirian Diamond Star Light (We are receiving Now) is Benefiting Us, and Our Multidimensional Personal & Collective Physical Ascension? (Sirian Star Beings Team - Message!) -How to Connect with These Energies, to TurboBoost YOUR Psychic Gifts, YOUR Light Body Brilliance & Open YOUR Prosperity Gates for the next 9 Years ahead (2024 to 2033)? ( Surprise Star Beings Team - Message!) -Madelina will do An 888 Lion's Gate Portal - Light Body Group Meditation & Activation - To Open Your Heart & Your AuraFields to A New Way of Creating Miracles in Any Area of Your Life, and Help Humanity, All Kingdoms & Mother Earth as Well! -PLUS, Join Us Live during the Q & A's - to Get Your Question Answered by Madelina & The Galactic Team - Receive A Personal Mini Reading & Light Body Activation for One Miracle You Would like to Create for Yourself, Your Loved One's, or for Mother Earth!  Madelina is A Multidimensional BioEnergy Intuitive - A Divine Love/Light & Sound Frequencies Transmitter & Soul Connector, A Way Shower, A Star Seed, and An Earth Light Grids Keeper. As An Ancient Soul - Clairsentient, and Empath - She Telepathically receives Messages from the Body's BioEnergetic Systems, the Divine/Soul/Higher Self, Angels/ Archangels/ Ascended Masters, and The Benevolent Galactics & Spirit Guides. Madelina is A Certified Medical Intuitive & Arcturian Reiki Master, and A Gifted BioEnergy Healer. During Groups and Private Sessions, Madelina Tunes in & Scans The Group Energy, or Personal BioField, Sharing with You the Soulful insights that She Receives, Channeling Divine Golden Light & Uplifting Sounds for BioEnergy Unblocking, Clearing, Balancing & Harmonization, as well as Self Empowerment Tools. Madelina also, conduct various Meditations, Activations & Processes, Helping People Worldwide with Her Unique - Multidimensional BioEnergy Divine Light/Sound/Sacred Geometry Frequency Transmission Technique - That was Gifted to Madelina from Mid 2018, by Her Divine Soul/Higher Self & The Arcturian Galactic Team. Madelina Loves to Empower You To Realign with Your Unique Original Divine Soul Song - To Reawaken Your Inner Power, Purpose & Innate Psychic Gifts, and Uplift Your Spirit - To Enjoy Emotional Harmony & Loving Relationships - To Restore Your Healthy BioEnergetic Systems & Reactivate Your Innate Healing Abilities - So You could Live Your Best Life NOW, and THRIVE!  Speaker Gifts: https://awakentohappinessnow.com Madelina's Offers: https://awakentohappinessnow.com/s35madelina/ #shefaliburns , #awakentohappinessnow, #healing, #energy, #transformation, #consciousness, #love, #consciousliving, #joy, #empowerment, #wellness, #spirituality, #spiritualawakening, #awareness, #madelinalight

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor's degree in Bioengineering from the University of California, Berkeley, his doctorate and master's degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.

Cassidy on the Gram and now Cassidy in the AW Studio! This woman can do it all! Encouraging and embracing all things women – whether that's in the office, in sneakers and giiiirl even in the club. She's a cool mom, with cool style, and a cool *couple, few, many* jobs. Tune in to this episode, Whiners, you're gonna love!Buy your tickets: Adultish Whines Live Podcast Follow the Pod: instagram.com/adultishwhines/Follow your Host: instagram.com/paige_crutcher/Follow Cassidy: instagram.com/cassidyonthegram/Follow Cassidy on LinkedIn for the Corporate Baddies + Side Hustlers Cassidy's unfiltered HR newsletter: yo-youre-on-mute.beehiiv.com/ Go to https://betterhelp.com/adultish for 10% off your first month of therapy with BetterHelp and get matched with a therapist who will listen and help #sponsoredUse code ADULTISH at adameve.com for 50% off, free gifts and free shipping.Use code AWCLUB at kingsofneon.com for 10% off a custom neon sign.

Teams are the new focal point of organizational design and organizational function. Motivation - quantified as “energy” by Proijal Ghatak and Onloop - is the key to team performance. Technology is advancing to the point where motivation can be monitored using AI, and self-reported feedback and other nuanced approaches to understanding and improving motivation levels are delivering real progress. Purpose portfolios can align individual motivations with organizational goals, capturing the role of purpose in driving productivity and engagement.Projjal mentioned companies experimenting with holocracy and distributed flat organizations, although scaling such structures was noted as challenging due to inherent human tendencies to seek direction and guidance. The conversation also explored frameworks like RAPID (Bain's Responsible, Accountable, Perform, Informed, Decide model) and spans of control, highlighting strategies for optimizing organizational effectiveness and managerial efficiency.Projjal emphasized the importance of respect and trust in leadership dynamics, noting that effective leaders inspire motivation and engagement through their actions and guidance. The role of AI in augmenting managerial capabilities and increasing spans of control was also discussed, highlighting the potential for technology to enhance organizational structures and improve managerial effectiveness.Resources: The Post-Managerial Era (Blog Post) Connect with Hunter Hastings on LinkedIn Connect with Projjal Ghatak on LinkedInonloop.comShow Notes:0:00 | Intro0:57 | Problem to Solve3:02 | Collaborative Software Tools Shift Mindsets9:31 | Great Breakthrough: Products Addressing Management Problems16:44 | HR's Original Design: Suppressing Dissent, Keeping Control17:44 | Teams as Core Units: Hybrid, Remote and Onsite21:41 | Entrepreneurial Intent Without Clear Goals25:11 | Feedback Loop26:19 | New Performance Management Project 31:25 | How Do Projjal Detect Motivation?35:29 | Experimenting with 'Things That Matter'38:15 | Service Orientation41:04 | Organization and Firm Structure50:40 | Right Hemisphere Dominant VS Left Hemisphere Dominant 53:19 | Wrap-Up

Welcome to the Hughes Hubbard Anti-Corruption & Internal Investigations Practice Group's podcast All Things Investigation. In this podcast, Tom Fox is joined by Jan Dunin-Wasowicz a partner at Hughes Hubbard & Reed, who is a leading figure in trade sanctions and Jeff Nielsen, International Sanctions & Export Controls Lawyer at Rambol, for a deep dive into current issues in export control and economic sanctions. In Part 2 of a special two-part series on All Things Investigations, host Tom Fox is once again joined by Jeff Nielsen and Jan Dunin-Wasowicz to discuss trade sanctions from a global perspective. In this Part 2, Jeff and Jan provide their expertise on the EU Directive on Harmonization of Criminal Sanctions, detailing its implications and the challenges faced in its implementation across the 27 member states. They explain the mechanics of EU sanctions, enforcement disparities among member states, and the directive's focus on setting minimum standards for criminal offenses. The conversation also delves into future outlooks on the EU's stance towards the Russian invasion of Ukraine and the evolving profession of trade sanctions compliance. Key Highlights: Understanding the EU Directive on Harmonization of Criminal Sanctions Challenges and Implications of the Directive Future of Trade Sanctions and Compliance Career Advice for Aspiring Trade Sanction Experts Conclusion and Final Thoughts Resources: Hughes Hubbard & Reed website Jeff Nielsen on LinkedIn Jan Dunin-Wasowicz on LinkedIn HHR client alert on The Dawn of a New Era for EU Sanctions Enforcement? EU Adopts Directive on the Definition of Criminal Offences and Penalties for the Violation of EU Sanctions

To help meet the U.S. Environmental Protection Agency (EPA) Superfund program's mandate to protect human health and the environment from current and potential threats posed by uncontrolled hazardous substance (both radiological and non-radiological), pollutant, or contaminant releases, the Superfund program has developed a human health evaluation process as part of its remedial response program. The process of gathering and assessing human health risk information is adapted from well-established chemical risk assessment principles and procedures. Within the Superfund remediation framework, radioactive contamination is dealt with in a consistent manner as with chemical contamination, except to account for the technical differences between radionuclides and chemicals. This consistency is important since at every radioactively contaminated site being addressed under Superfund's primary program for long-term cleanup, the National Priorities List (NPL), chemical contamination is also present. To view this archive online or download the slides associated with this seminar, please visit http://www.clu-in.org/conf/tio/remedial-radrisk_052224/

To help meet the U.S. Environmental Protection Agency (EPA) Superfund program's mandate to protect human health and the environment from current and potential threats posed by uncontrolled hazardous substance (both radiological and non-radiological), pollutant, or contaminant releases, the Superfund program has developed a human health evaluation process as part of its remedial response program. The process of gathering and assessing human health risk information is adapted from well-established chemical risk assessment principles and procedures. Within the Superfund remediation framework, radioactive contamination is dealt with in a consistent manner as with chemical contamination, except to account for the technical differences between radionuclides and chemicals. This consistency is important since at every radioactively contaminated site being addressed under Superfund's primary program for long-term cleanup, the National Priorities List (NPL), chemical contamination is also present. To view this archive online or download the slides associated with this seminar, please visit http://www.clu-in.org/conf/tio/remedial-radrisk_052224/

Will there be a future return to animal sacrifices when Christ returns? If that's what the Bible says, how would such a position reconcile with the all-sufficient sacrifice of Jesus on the cross? Peter looks deeply into these questions by analyzing a chapter from Matt Waymeyer on how one can reconcile a future temple and return to sacrifices with the book of Hebrews. Time Stamps: 00:00 Introduction to Importance of Topic 06:29 Texts Dealing with a Future Temple 11:40 Different Views on Future Sacrifices 13:26 View 1: Symbolic View 20:30 View 2: Memorial View 26:33 View 3: Ceremonial Cleansing View 31:51 The Nature of Atonement in Ezekiel 40-48 37:37 The Sacrificial System in the OT and Ezekiel 41:47 Harmonization with Hebrews 9-10 44:37 The Absence of the Day of Atonement in Ezekiel 47:35 The Broad Language of Hebrews 50:42 Paul's Example in Acts 21 59:15 Outro Article referenced on the prophetic expectation for a future temple: https://petergoeman.com/does-the-bible-say-there-will-be-a-future-temple-in-israel/ Book Referenced in Episode in Honor of Larry Pettegrew: https://www.amazon.com/dp/1959454005 Amillennialism and the Age to Come (Matt Waymeyer): https://www.amazon.com/dp/1934952257/ Matt Waymeyer on Revelation 20: https://www.youtube.com/watch?v=YylmWRfjqJU If you have found the podcast helpful, consider ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠leaving a review on Itunes⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ or ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠rating it on Spotify⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. You can also find ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠The Bible Sojourner on Youtube⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. Consider passing any episodes you have found helpful to a friend. Visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠petergoeman.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ for more information on the podcast or blog. Visit⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ shepherds.edu⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ for more on Shepherds Theological Seminary where Dr. Goeman teaches.

Will there be a future return to animal sacrifices when Christ returns? If that's what the Bible says, how would such a position reconcile with the all-sufficient sacrifice of Jesus on the cross? Peter looks deeply into these questions by analyzing a chapter from Matt Waymeyer on how one can reconcile a future temple and return to sacrifices with the book of Hebrews. Time Stamps: 00:00 Introduction to Importance of Topic 06:29 Texts Dealing with a Future Temple 11:40 Different Views on Future Sacrifices 13:26 View 1: Symbolic View 20:30 View 2: Memorial View 26:33 View 3: Ceremonial Cleansing View 31:51 The Nature of Atonement in Ezekiel 40-48 37:37 The Sacrificial System in the OT and Ezekiel 41:47 Harmonization with Hebrews 9-10 44:37 The Absence of the Day of Atonement in Ezekiel 47:35 The Broad Language of Hebrews 50:42 Paul's Example in Acts 21 59:15 Outro Article referenced on the prophetic expectation for a future temple: https://petergoeman.com/does-the-bible-say-there-will-be-a-future-temple-in-israel/ Book Referenced in Episode in Honor of Larry Pettegrew: https://www.amazon.com/dp/1959454005 Amillennialism and the Age to Come (Matt Waymeyer): https://www.amazon.com/dp/1934952257/ Matt Waymeyer on Revelation 20: https://www.youtube.com/watch?v=YylmWRfjqJU If you have found the podcast helpful, consider ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠leaving a review on Itunes⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ or ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠rating it on Spotify⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. You can also find ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠The Bible Sojourner on Youtube⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. Consider passing any episodes you have found helpful to a friend. Visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠petergoeman.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ for more information on the podcast or blog. Visit⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ shepherds.edu⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ for more on Shepherds Theological Seminary where Dr. Goeman teaches.

Many organizations going through digital transformations do so because they want to harmonize the systems that they have. But what exactly is system harmonization and what can we do to achieve that? That's what I will be discussing today. #digitalstrategy #digitaltransformation #interoperability ORDER MY NEW BOOK: The Final Countdown: https://thefinalcountdown.com/

In this episode we will be chatting about :- DNA activation and cosmic consciousness, - Shifts in human capabilities and awareness- New sequences of DNA work- Genetic blueprints - Identity across different timelines- The higher self, galactic self and God self - The concept of sound and its role in organizing matter and consciousnessInfinite love ~ Sonia GLet's stay connected!Instagram : @moonbabesandthelighttribeWebsite : www.moonbabetribe.com

For a company that has been around since 1911, Mars has a reputation as one of the most visionary companies in the industry, particularly when it comes to building global capabilities that scale and flex to serve the needs of the regional lines of business. It's not any easy feat. Celia Van Wickel, Director Omnichannel Digital Commerce Analytics at Mars, drives building out their global digital commerce analytics strategy, and works closely with the business to design, test and scale capabilities that deliver efficiency, measure results, and identify opportunities for growth. She kindly agreed to join the podcast to share the art and science for enabling digital commerce analytics to every region around the world.

In the Gospels, we get four resurrection narratives.  At first glance, there seems to be some dissonance and even contradictions between these four accounts. Let's dive in and see how beautifully the gospels harmonize to tell the most amazing event in all of history!

 Sponsor: Medboard   EU EU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey - Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf   Spain: AEMPS consultation - Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/ EURL Second Call - More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en TEAM-NB Position Paper - Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/02/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf EMDN Proposal - Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/ MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf   Training Training Green Belt EU MDR - Learn by practicing: https://school.easymedicaldevice.com/course/gb30 Open March 25th, 2024 until March 29th, 2024TEAM-NB Training - Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdfApril 29th, 2024   Services Packaging and IFU - Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/   ROW USA Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device   CANADA Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html   Mexico Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es   Saudi Arabia  SFDA Harmonized Standards - Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf   Qatar  Qatar Telemedicine - Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf   Australia TGA SOPP requirements - System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf TGA Essential Principles - Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls: https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf   https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf   PODCAST Episode 271 - How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/ Episode 272 - Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/ Episode 272 - New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/   EASY MEDICAL DEVICE Services: Training: https://school.easymedicaldevice.com/emd-course/ Authorized Representative EU: https://easymedicaldevice.com/eu-rep/ Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/ Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/ Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/ Eqms SmartEye; https://smart-eye.io Conferences: https://medtechconf.com/  

The Great Taking : Uncovering Economic Manipulation with Peak Prosperity Part 1 of 4. The global economic system is being manipulated by hidden individuals and institutions, leading to a concentration of wealth and power, intentional induced financial crises, and the dematerialization of securities, and that this system must be dismantled non-violently. It's important because it answers the question, “How exactly will I end up owning nothing as the WEF has prognosticated?” If you'd rather not lose all your wealth to a bunch of amoral Wall Street crooks in a legalized transfer of wealth, then this series is for you.   Watch this presentation at-  https://youtu.be/O3pq0WURDW8?si=prX2zdDTcEX-fn1L Peak Prosperity 512K subscribers 14,019 views Premiered 2/16/2024  #podcast #stockmarket #economy Join the Conversation (and download the audio book) here (Free): https://peak-prosperity.com/GrtTaking... Continuation to Part 1 found here: https://peak-prosperity.com/GTContinued Original David Webb interview that kicked this research off found here:: Part 1 (Free): https://peak-prosperity.com/DWEBB Part 2 (Free): https://peak-prosperity.com/DWEBBprt2 For more information on our amazing new webinar series - Prospering With Integrity with Bret Weinstein, Ed Dowd and Peter St Onge, click here: https://peak-prosperity.com/PWI4

In this podcast, host Steve Farrell is joined by pioneers in sound healing, collaborators, and dear friends of Humanity's Team Jonathan & Andi Goldman, for an incredible collective and soul-cleansing 22nd annual World Sound Healing Day. During this discussion with Jonathan and Andi, you will learn of the sounds made to send love, compassion, and understanding to the Gaia Matrix and how the power of sound healing will lead our Global Collective to a higher state of consciousness.  In this podcast, you will discover… The way sound fosters harmony on the planet  The origin of World Sound Healing Day      What the concept of seperated self is The effects of sound healing and intention   How to listen without judgement and with compassion   And much, much more…  ***Note: this is a special rebroadcast, and any websites, links, programs, or events mentioned may no longer be active (or dates may have been changed). Thank you!*** For more teachings and rich healing experiences with The Goldmans, be sure to check out Humanity Stream+ here, where you will find dozens of great programs with them Explore Humanity's Team and the timeless truth that We Are All One.  Learn more about the Humanity's Team free education programs.  

This week Leonard Bailey, Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit for the Department of Justice (DOJ), Criminal Division, joins us this week. We dive into the role of the DOJ in addressing the vast and ever-changing landscape of cybersecurity. Bailey shares insights on partnering with federal agencies as well as the private sector, navigating information sharing pathways, evolution of incident and cyber threat reporting procedures, and the recent release of the Harmonization of Cyber Incident Reporting to the Federal Government. He also helps debunk information sharing myths and spotlights available tools and benefits of cyber threat information disclosure.   Leonard Bailey The Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit and Special Counsel for National Security in the Department of Justice's (DOJ) Criminal Division. He has prosecuted computer crime cases and routinely advised on cybersecurity, searching and seizing electronic evidence, and conducting electronic surveillance. He has managed DOJ cyber-policy as Senior Counselor to the Assistant Attorney General for the National Security Division and then as an Associate Deputy Attorney General. He has also served as Special Counsel and Special Investigative Counsel for DOJ's Inspector General. Bailey is a graduate of Yale University and Yale Law School. He has taught law courses at Georgetown Law School and Columbus School of Law in Washington, DC. For links and resources discussed in this episode, please visit our show notes at https://www.forcepoint.com/govpodcast/e267

s we leave an exciting 2023, it's time to enter a new year. Without a doubt, the sustainability sector is witnessing transformative trends and predictions reshaping how businesses operate and consumers engage. This week, we discuss our thoughts as we enter 2024 and provide an in-depth look at these key trends and predictions our team has complied: Global supply chains under the microscope–The focus on transparency and public reporting within global supply chains has become more pronounced. This year, we're seeing a significant shift towards improving data accessibility, with large corporations and smaller suppliers under increased scrutiny. The emphasis is on creating a transparent supply network where every participant is accountable for their sustainability practices.The rise of technological integration–Integrating digital tools is set to revolutionize sustainability practices in supply chains and beyond. Developers and industry leaders expect these technologies to streamline processes, enhance transparency, and deliver comprehensive insights into supply chain operations.Regulatory changes driving action–Anticipated regulatory changes, especially from bodies like the Securities and Exchange Commission (SEC), push organizations to rethink and readjust their sustainability strategies. Companies are gearing up for new requirements, like calculating scope three emissions and preparing for third-party audits, signaling a shift towards more rigorous sustainability compliance.Harmonization in reporting standards–Industry leaders are actively aligning various sustainability reporting standards, like the SBTI and CSRD, to simplify compliance processes. This harmonization effort targets making it easier for organizations, especially those with limited resources, to meet sustainability reporting requirements. This trend is driving a more unified and coherent approach to sustainability reporting.Private equity's growing influence–The influence of private equity in shaping sustainability practices is becoming increasingly apparent–initiatives like the ESG Data Convergence guide firms towards more standardized reporting and actionable sustainability measures. This trend reflects the growing role of private equity in promoting sustainable practices among portfolio companies.Sustainability conversations in the boardroom–Environmental, Social, and Governance (ESG) topics are now taking center stage in corporate boardroom discussions. There is a heightened focus on genuine decarbonization efforts, avoiding greenwashing, and ensuring that concrete actions back public sustainability claims. This shift underscores the growing importance of sustainability in corporate governance and strategic decision-making. It will be interesting to look back a year from now and see how this year's predictions pan out. Many of these trends highlight a dynamic and evolving landscape in the sustainability sector for 2024, marked by increased accountability, technological advancement, regulatory alignment, and strategic corporate focus on genuine sustainability practices.

In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance.Quotes"We're seeing pushes into adaptive algorithms... algorithms that modify themselves in the field without human oversight." - Eric Henry"The FDA and other regulators are no stranger to the issues in generative AI as well." - Eric Henry"Keep an eye on the FTC... they have a tool called algorithmic discouragement, which can have significant implications for AI in life sciences." - Eric HenryTakeawaysFTC's Growing Role: The FTC may soon have broader enforcement authority over AI across various industries in the U.S.Algorithmic Discouragement: A tool that allows the FTC to force companies to delete an algorithm and all its associated training data.Evolving Regulatory Landscape: The FDA is adapting its regulatory framework to accommodate AI, focusing on adaptive and generative AI.Challenges with Locked Algorithms: Current regulatory frameworks primarily support locked algorithms, but there's a movement towards adaptive algorithms.Impact of AI on Quality Systems: AI is set to revolutionize quality management systems and manufacturing processes in the life sciences.Importance of Pre-Market and Post-Market Oversight: Both are crucial for ensuring the safety and efficacy of AI-driven medical devices.The Role of CSA in AI Integration: The transition from CSV to CSA could influence how AI is integrated into software systems.Harmonization of Standards: A significant challenge in AI regulation is the harmonization of numerous standards being developed globally.Public-Private Partnerships: Collaborations like the AI Global Health Initiative are vital for advancing regulatory frameworks in AI.The Need for Industry Engagement: Active involvement in AI-focused organizations can help businesses navigate the evolving regulatory landscape.ReferencesVisit www.greenlight.guru for insights on streamlining product development in Medtech.Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance.Explore the AI Global Health Initiative under AFDO and RAPS sponsorship.For questions or consultations, contact Eric Henry at ehenry@kslaw.comVisit Greenlight Guru to learn more how to prepare your QMS for the future of MedTech.Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback.

A Harmonization of the Christmas Gospels

Artificial intelligence holds the promise of revolutionizing disease diagnosis and prediction, but it also presents a pivotal challenge: ensuring equity. In this Q&A, Alondra Nelson, PhD, the Harold F. Linder Professor at the Institute for Advanced Study, joins JAMA's Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, to discuss the equitable regulation of AI to benefit all populations. Related Content: How Do Policymakers Regulate AI and Accommodate Innovation in Research and Medicine?

“Platforms harmonize and standardize without restricting. By standardizing, they actually enable and allow people to do more things." Gregor Hohpe is back again for the second episode with his latest book “Platform Strategy”. In this episode, Gregor discussed in-depth about building platforms with a proper platform strategy. He began by describing what a platform is from a few different perspectives, the benefits it brings, and what strategy we should think about when building a platform. Gregor also emphasized the opposite difference between platforms and IT services, with the key difference of how a platform thrives with more scale. We then had a few fun discussions discussing building a platform on top of a cloud platform, the key skillset we need to build a good platform, and how we should build a proper platform abstraction. Towards the end, Gregor also covered the recent trend of building developer platforms and business capability platforms. Also, do not miss Gregor's fun analogy of fruit basket vs fruit salad when explaining a good platform strategy.   Listen out for: Strategy Book Series - [00:05:39] Definition of Platform - [00:07:58] Platform Benefits - [00:12:09] Platform Strategy - [00:17:25] Platform vs IT Service - [00:20:47] Platform Thrives With Scale - [00:25:39] Cloud Platform-Based Platform - [00:29:36] Skillset for Building Platform - [00:36:44] Abstraction, Not an Illusion - [00:44:19] Fruit Salad vs Fruit Basket - [00:47:32] Developer Platform - [00:51:34] Business Capability Platform - [00:55:48] 3 Tech Lead Wisdom - [00:59:31] _____ Gregor Hohpe's BioGregor Hohpe advises CTOs and senior IT executives on IT strategy, cloud architecture, and organizational transformation. He served as advisor to the Singapore government, chief architect at Allianz SE, and technical director at Google Cloud's CTO Office. He is widely known as co-author of the seminal book “Enterprise Integration Patterns” and as frequent speaker at conferences around the world. His accessible, but technically accurate essays were republished in “97 Things Every Software Architect Should Know” and “Best Software Writing”. He is an active member of the IEEE Software editorial advisory board. Follow Gregor: Website – https://architectelevator.com/ LinkedIn – linkedin.com/in/ghohpe/ X – @ghohpe Platform Strategy (with special coupon for TLJ listeners) – https://leanpub.com/platformstrategy/c/techlead _____ Our Sponsors Are you looking for a new cool swag? Tech Lead Journal now offers you some swags that you can purchase online. These swags are printed on-demand based on your preference, and will be delivered safely to you all over the world where shipping is available. Check out all the cool swags available by visiting techleadjournal.dev/shop. And don't forget to brag yourself once you receive any of those swags. Like this episode? Show notes & transcript: techleadjournal.dev/episodes/156 Follow @techleadjournal on LinkedIn, Twitter, and Instagram. Buy me a coffee or become a patron.

Do you want to live a blissfully balanced life?In this episode of the Happy Hustle Podcast, I'm diving into the nitty-gritty of the systematic harmonization of ambition and well-being – what we like to call the Happy Hustle. Let's start with the basics. What is the Happy Hustle? It's all about persevering past adversity with a smile, symbolized by our cute logo with the X over the eye. But what intrigued people was the 'Happy Hustle' part. So, I dug deep and defined it as the systematic harmonization of ambition and well-being.Systematic means the execution of a fixed plan or system methodically. So, to achieve the harmonization, you need a methodical plan. It's not just a feel-good theory; it's a tangible roadmap. Because, let's face it, balance equals happiness. Now, ambition – it's that strong desire to achieve something, requiring determination and hard work. That's the hustle part. Well-being, on the other hand, is the state of being comfortable, healthy, and happy. Combine the two, and you've got the systematic harmonization of ambition and well-being – And that's the essence of the Happy Hustle.You might ask, how to make this systematic harmonization happen? It's the S.O.U.L.M.A.P.P.I.N Framework. This unique and proprietary system consists of 10 key areas of life that you need to focus on to achieve blissful balance, both personally and professionally.S.O.U.L.M.A.P.P.I.N breaks down into 10 key areas of life, forming the acronym itself:Selfless service – give your time, money, and efforts to causes you believe in.Optimized health – mentally, physically, emotionally optimized for peak performance.Unplug digitally – create intentional barriers in our hyper-connected world.Loving relationships – give yourself fully to family, friends, and your partner.Mindful spirituality – connect to something higher, whatever that means for you.Abundance financially – save, spend, and invest wisely for ultimate freedom.Personal development – grow and evolve every day, don't shrink and dissolve.Passionate hobbies – do things that bring you joy and create space for yourself.Impactful work – infuse your passion and purpose into your career.Nature connection – get outside, connect with the planet, and protect it.So that's the Happy Hustle, a blueprint for systematically harmonizing ambition and well-being. Whether you're a seasoned hustler or just starting out, this approach will transform your life.If you want to dive even deeper into this transformational journey, check out my book, The Happy Hustle 2.0. It's packed with scientific research, frameworks, acronyms, and happy hustle hacks. Pre-order now and get $350 worth of bonuses at thehappyhustle.com/book.Connect with Cary!https://www.instagram.com/cary__jack/https://www.facebook.com/SirCaryJackhttps://www.linkedin.com/in/cary-jack-kendzior/https://twitter.com/thehappyhustlehttps://www.youtube.com/channel/UCFDNsD59tLxv2JfEuSsNMOQ/featuredGet a free copy of his new book, The Happy Hustle, 10 Alignments to Avoid Burnout & Achieve Blissful Balance https://www.thehappyhustle.com/bookSign up for The Journey: 10 Days To Become a Happy Hustler Online Course http://www.thehappyhustle.com/JourneyApply to the Montana Mastermind Epic Camping Adventure https://caryjack.com/montana“It's time to Happy Hustle, a blissfully balanced life you love, full of passion, purpose, and positive impact!” Episode sponsor BIOptimizers Magnesium BreakthroughThis stuff is a game-changer! Magnesium Breakthrough packs all 7 forms of magnesium, designed to support stress management, promote muscle relaxation, regulate the nervous system, control stress hormones, boost brain function, increase energy, and enhance sleep.I take 2 capsules before bedtime, and it's been a game-changer for me. The best part is, BIOptimizers offer a risk-free 365-day money-back guarantee. No results, no problem – they'll refund you, no questions asked. It's a win-win!Head over to magnesiumbreakthrough.com/hustle and use code "hustle" for an exclusive 10% discount on any order. Plus, for a limited time, you'll score some special gifts with your purchase.BELAY Solutions (https://resources.belaysolutions.com/happyhustle?utm_campaign=The%20Happy%20Hustle&utm_source=email&utm_medium=Email%20Newsletter%20-%20D2E&utm_content=HH%20Native%20Ad%201)BELAY is a flexible staffing solution that helps busy leaders find the right help. 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Welcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials.Tune in!During this episode, you will learn about;0:00:49 - ICH Introduction0:02:13 - The Significance of ICH E6 and E80:04:41 - The Global Impact of ICH 0:08:02 - The Evolution of Technology0:11:30 - Quality by Design 0:18:51 - Operational Feasibility0:21:16 - Complementary Guidance            Love the show? Subscribe, Rate, Review, Like, and Share!Let's Connect!Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com

Wiley's cyber team talks about cyber incident reporting after a new report from DHS advising Congress on duplication of reporting regimes. With over 50 reporting requirements spread over 20 agencies, federal agencies and the private sector should heed this report and look for ways to reduce burdens. Harmonization will be all the more challenging after the Securities and Exchange Commission (SEC) finalized controversial new reporting mandates, as DHS is developing major new reporting rules, and other agencies adopt and propose varied and different reporting requirements. Indeed, just this week, the Federal Acquisition Regulation Council dropped yet more reporting mandates for federal contractors. This podcast comes in the wake of news of a recent leak to the press of cyber attack information reported to the government by a prominent government contractor, illustrating the sensitivity of these issues. Join Megan Brown, Lyn Brown, and Josh Waldman for a discussion of the new report and what is on the horizon for cyber incident reporting.

In this week's Security Sprint, Dave and Andy talked about the following topics. Security Planning CISA: New Product - Protecting Houses of Worship: Perimeter Security Considerations Infographic. The Cybersecurity and Infrastructure Security Agency (CISA) released the Protecting Houses of Worship: Perimeter Security Considerations Infographic. CISA: Security Planning Workbook. Security Planning Workbook (PDF) DHS: This #SeeSayDay Take the Pledge to Protect Your Community If You See Something, Say Something® #SeeSayDay.  Selected FB reports: Statement from President Joe Biden on Yom Kippur Synagogues brace for bomb threats, ‘swatting' attacks as Yom Kippur begins Escambia County church a 'total loss' after overnight fire Bomb Threat Forces Evacuation at Screening of John MacArthur's ‘The Essential Church' at G3 National Conference Anne Arundel police announce arrests in three hate bias cases at area churches FBI WARNED SIKHS IN THE U.S. ABOUT DEATH THREATS AFTER KILLING OF CANADIAN ACTIVIST INVITATION: Protecting Places of Worship Weeks of Action Virtual Events + DHS Resources Bomb threats target US synagogues during Rosh Hashanah West Virginia Man Admits to Obstructing Tree of Life Trial TikTok Shoplifting Threats. https://www.the-sun.com/news/9148713/retail-chains-tiktok-videos-shoplifting-warning-employees/ Jen Walker, Superstar, and Ransomware Resilience Congratulations to our 2023 SC Media Women in IT Security honorees. “Today SC Media shines a spotlight on 20 business leaders as part of our 2023 Women in IT Security program. Thank you to SC Media for recognizing Gate 15's very excellent Jennifer Lyn Walker in the 2023 Women in IT Security list‼️ Private Public Partnership. FBI Director Christopher Wray Speaks at 2023 mWISE Cybersecurity Conference. Cyberspace Solarium Commission's (CSC's) 2023 Annual Report on Implementation. Key Takeaways from the 2023 Security Summit Hosted at the Fortinet Championship. Ransomware. House Oversight Committee: Combating Ransomware Attacks MGM Resorts are operating ‘normally' after hacks, sort of TribalNet: Cyber experts wrap up MGM hack at San Diego conference. The MGM Breach and the Role of IdP in Modern Cyber Attacks TribalNet: Gaming tech exec says it's time finally to talk about cybersecurity MGM vs. Caesars: Cybersecurity Expert Rates Hacking Responses PhilHealth hit by Medusa ransomware, aims for site restoration by Monday Ransomware group claimed to have hit a New Jersey cardiology group. Did they? Growing Ransomware Threats: Looming Danger for ICS, Industrial Companies   Morroco disaster scams / misinformation on social media, scams The Gate 15 Interview: Malicious Info Operations & MDM, the Space Sector, supply chain resilience, the City of Light, and nudging the world in a better direction. Misinformation research is buckling under GOP legal attacks GOP legal attacks create a chilling effect on misinformation research The Rise of Generative AI and the Coming Era of Social Media Manipulation 3.0   Quick Hits: Perspective: Homeland Security and the Shutdown Threat: Planning for an Unnecessary Contingency Alarm bells ring as lawmakers prep for possible shutdown U.S. braces for calamitous, costly government shutdown in eight days IT-ISAC: Cyber experts set out plan to secure crucial 2024 US election Health-ISAC QR Codes. https://www.aha.org/h-isac-white-reports/2023-09-19-h-isac-tlp-white-observed-increase-qr-code-phishing-attacks-september-19-2023 Harmonization of Cyber Incident Reporting to the Federal Government. El Nino winter. https://www.cnn.com/2023/09/25/weather/el-nino-winter-us-climate/index.html    

Rita and Vija explore what it meant for Jacob, and for the disciples in the storm, to wrestle. How have other people struggled with their consciences, and their internal and external obstacles? How do you wrestle?Sermon begins at minute marker 8:18Genesis 32.22-30, Luke 8.22-25ResourcesAnnie Dillard's quote comes from her book Teaching a Stone to TalkQuote from Meister Eckhart: “The eye through which I see God is the same eye through which God sees me; my eye and God's eye are one eye, one seeing, one knowing, one loving.” Quote from Louise Penny in Glass Houses: She features a cobrador, a “cloaked figure acting as a conscience to those without one, forcing payment of a moral debt.”Image: VijaHymn: VT 595  When the Storms of Life Are Raging. Music and text, Charles A. Tindley. Harmonization, William Farley Smith ©1989 United Methodist Publishing House.  Permission to podcast the music in this service obtained from One License with license #A-726929. All rights reserved.

With 45 different cyber incident reporting requirements in place across the federal government, and even more on the way, the Department of Homeland Security is recommending the adoption of a standard definition for a “reportable cyber incident” and a common form organizations can use to comply with the different rules. DHS today released a report on “Harmonization of Cyber Incident Reporting to the Federal Government.” The document, at more than 100 pages long, provides detailed recommendations for streamlining different incident reporting rules. “It is imperative that we streamline these requirements,” DHS Under Secretary for Policy Rob Silvers, chairman of the council, said in a statement released with the report. “Federal agencies should be able to receive the information they need without creating duplicative burdens on victim companies that need to focus on responding to incidents and taking care of their customers.” Learn more about your ad choices. Visit megaphone.fm/adchoices

With 45 different cyber incident reporting requirements in place across the federal government, and even more on the way, the Department of Homeland Security is recommending the adoption of a standard definition for a “reportable cyber incident” and a common form organizations can use to comply with the different rules.DHS today released a report on “Harmonization of Cyber Incident Reporting to the Federal Government.” The document, at more than 100 pages long, provides detailed recommendations for streamlining different incident reporting rules.“It is imperative that we streamline these requirements,” DHS Under Secretary for Policy Rob Silvers, chairman of the council, said in a statement released with the report. “Federal agencies should be able to receive the information they need without creating duplicative burdens on victim companies that need to focus on responding to incidents and taking care of their customers.” Learn more about your ad choices. Visit podcastchoices.com/adchoicesSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

#TrueNorth Podcast | IpX experts Brandy Taylor and Michael Benning explore the challenges and strategies of aligning processes across diverse divisions and products while designing them with business goals in mind, maintaining balance, and considering deviations when necessary. They highlight communication, stakeholder support, and adaptability as key factors to success and provide insights into the complexities of achieving process harmonization while emphasizing strategic problem-solving and effective communication. This episode is hosted by IpX's Deanna Hensley.Watch this episode on YouTube.​​This podcast was based Michael Benning's blog, "Finding and Achieving the Appropriate Level of Process Standardization."Connect with IpX to hear more industry thought leaders. Learn how IpX can help your organization evolve with our functional blueprint for the ecosystem of tomorrow. Drive innovation, create a better customer experience, and enable your workforce as an organization built for change, speed, quality and resiliency. www.IpXhq.comStay in touch with us! Follow us on social: LinkedIn, Twitter, Facebook Contact us for info on IpX or for interest in being a podcast guest: info@ipxhq.com All podcasts produced by Elevate Media Group.

Immerse yourself in a deeply relaxing and meditative experience with the soothing melodies of the Native American flute, accompanied by the tranquil sounds of a gentle waterfall and rain. This combination creates an environment that encourages relaxation, inner peace, and a heightened sense of serenity. The enchanting tones of the Native American flute carry you on a journey of tranquility, evoking a connection with nature and the spirit of ancient wisdom. The melodic and soulful melodies played on the flute resonate with your being, allowing you to release tension and find inner harmony. As the flute music weaves its way through your senses, the gentle sounds of a waterfall and rain provide a backdrop of natural serenity. The cascading water and gentle raindrops create a soothing and rhythmic ambiance, inviting a sense of calm and stillness into your space. Together, the Native American flute music, waterfall sounds, and rain create a harmonious symphony that calms the mind, eases stress, and promotes deep relaxation. It is an invitation to let go of worries, immerse yourself in the present moment, and find solace in the beauty of nature's embrace. Whether you are seeking solace, practicing meditation, or simply desiring a moment of tranquility, allow yourself to be carried away by the enchanting melodies of the Native American flute, harmonized with the peaceful sounds of a waterfall and rain. Let this immersive experience transport you to a state of deep relaxation, where you can reconnect with your inner self and find solace in the gentle embrace of nature's symphony. Relax, Meditate, Soothing, Native American flute music, Calming sounds, Waterfall, Rain, Environment, Relaxation, Inner peace, Serenity, Melodies, Connection, Nature, Ancient wisdom, Tension release, Inner harmony, Senses, Cascading water, Raindrops, Rhythmic ambiance, Calmness, Stillness, Space, Symphonic harmony, Mind calming, Stress reduction, Deep relaxation, Letting go, Present moment, Solace, Beauty, Nature's embrace, Seeking solace, Meditation practice, Tranquility, Immersive experience, Enchanting melodies, Harmonization, Peaceful sounds, Transport, Reconnect, Inner self, Gentle embrace, Nature's symphony. Support our mission of spreading relaxation and wellness by rating and reviewing our podcast on your preferred platform. Your feedback helps us improve and enables others to discover the benefits of our soothing sounds. Enhance your listening experience by subscribing to our ad-free version, immersing yourself in uninterrupted tranquility.  Clicking Here  Join our community of relaxation seekers and embark on a journey of self-discovery. Subscribe, rate, and review Meditation Sounds today and unlock a world of serenity and rejuvenation.  Email List Support this podcast  https://www.meditationsoundspodcast.com Say goodbye to stubborn belly fat with our revolutionary product! Our formula is designed to target and dissolve unwanted fat, leaving you with a slimmer, more toned midsection. Try it now and experience the results for yourself. #dissolvebellyfat #slimandtoned http://bit.ly/3jV1Ip1 Learn more about your ad choices. Visit megaphone.fm/adchoices

Unleash the power of your Root Chakra with our specially crafted music designed to unblock and energize this foundational energy center. The Root Chakra, also known as the Muladhara Chakra, is located at the base of the spine and is associated with feelings of stability, security, and grounding. Our music for the Root Chakra works to remove any blockages or imbalances that may be hindering the flow of energy in this vital energy center. By listening to this music, you can activate and harmonize your Root Chakra, allowing its energy to flow freely and bringing a sense of balance and stability to your life. The rhythmic beats and deep tones of the music resonate with the frequency of the Root Chakra, helping to ground and anchor your energy. As you listen, you may feel a sense of rootedness and connection to the Earth, allowing you to feel more grounded and centered in your daily life. This music serves as a powerful tool for healing and balancing your Root Chakra. It helps you release any fears, insecurities, or feelings of instability that may be holding you back. By unblocking and energizing your Root Chakra, you can cultivate a strong foundation for personal growth, stability, and a sense of security in your life. Allow the music to guide you on a journey of self-discovery and empowerment. As you listen, focus your attention on your Root Chakra, visualize it as a vibrant red spinning wheel of energy, and feel the music resonating with this energy center. Allow any stagnant or blocked energy to be released, making room for renewed vitality and a sense of inner strength. By regularly listening to this music and working with your Root Chakra, you can experience a greater sense of stability, security, and groundedness in all aspects of your life. Embrace the power of your Root Chakra and unlock its potential for strength, resilience, and a deep connection to the Earth. Root Chakra, Muladhara Chakra, Stability, Security, Grounding, Unblock, Energize, Energy Center, Blockages, Imbalances, Flow of Energy, Activation, Harmonization, Balance, Rhythmic Beats, Deep Tones, Frequency, Grounding, Anchoring, Connection to Earth, Rootedness, Centeredness, Healing, Personal Growth, Stability, Security, Release, Empowerment, Self-Discovery, Red Spinning Wheel, Vibrant Energy, Stagnant Energy, Renewed Vitality, Inner Strength, Regular Practice, Stability, Resilience, Connection to Earth. Support our mission of spreading relaxation and wellness by rating and reviewing our podcast on your preferred platform. Your feedback helps us improve and enables others to discover the benefits of our soothing sounds. Enhance your listening experience by subscribing to our ad-free version, immersing yourself in uninterrupted tranquility.  Clicking Here  Join our community of relaxation seekers and embark on a journey of self-discovery. Subscribe, rate, and review Meditation Sounds today and unlock a world of serenity and rejuvenation.  Email List Support this podcast  https://www.meditationsoundspodcast.com Say goodbye to stubborn belly fat with our revolutionary product! Our formula is designed to target and dissolve unwanted fat, leaving you with a slimmer, more toned midsection. Try it now and experience the results for yourself. #dissolvebellyfat #slimandtoned http://bit.ly/3jV1Ip1 Learn more about your ad choices. Visit megaphone.fm/adchoices

Pink Sheet reporters and editors discuss CMS's latest coverage announcement for Alzheimer's drugs and the VA's approach to the issue (0:29), the FDA's new one-page patient medication information document (15:55), international convergence on COVID-19 vaccine strain selection (24:48), and Novavax's place in the vaccine toolbox going forward (28:21). Read More In The Pink Sheet Medicare Registry Plan For Alzheimer's Drugs Pairs CMS Web Portal With Health System Efforts https://pink.pharmaintelligence.informa.com/PS148313/Medicare-Registry-Plan-For-Alzheimers-Drugs-Pairs-CMS-Web-Portal-With-Health-System-Efforts The US VA And Alzheimer's: A Misunderstood Decision https://pink.pharmaintelligence.informa.com/PS148214/The-US-VA-And-Alzheimers-A-Misunderstood-Decision One-Page Patient Medication Information Document Moves Forward Under Proposed Rule https://pink.pharmaintelligence.informa.com/PS148298/One-Page-Patient-Medication-Information-Document-Moves-Forward-Under-Proposed-Rule International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine https://pink.pharmaintelligence.informa.com/PS148301/International-Regulators-Focus-On-Omicron-XBB-For-Monovalent-COVID-19-Vaccine Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability https://pink.pharmaintelligence.informa.com/PS148261/Novavax-Readying-Multiple-COVID-19-Vaccine-Candidates-To-Ensure-Fall-Availability

Throughout the Biden administration and this Congress, spectrum has been a priority for nearly everyone else in the world—except for us. We're currently 378 megahertz behind other countries on mid-band spectrum, a vital resource for 5G communications quality. Spectrum isn't anything we can see or touch, yet it's all around us. However it is perhaps the most important infrastructure for our modern age as more and more tech communicates wirelessly. It is also a finite resource, which makes changes to its allocation exceedingly touchy. How can we navigate this pressing allocation issue within a context of selfishness and scarcity?To walk us through what is holding us back on spectrum, we have Roger Entner back on the podcast. Entner is the founder of Recon Analytics, but his vast telecommunications experience includes being the senior vice president and head of research at Nielsen Media Research.In this episode, Shane reiterates spectrum's necessity while Roger identifies the smoking gun. Tune in as they band together on the precious resource of spectrum!